NCT05189496

Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Radiotherapy is one of the important treatments to improve the survival rate of breast cancer patients, but also has the risk of radiation lung injury, which can develop into pulmonary fibrosis. Hyperbaric oxygen can improve the tissue after radiation by promoting the function of vascular endothelial cells and fibroblasts, and reducing the secretion of inflammatory factors, thereby inhibiting the process of fibrosis and fiber atrophy after radiotherapy, and promoting tissue repair. Therefore, it has the potential value of treating chronic radiation injury. We aim to investigate whether hyperbaric oxygen treatment can reduce the incidence of radiation pneumonia and improve patients' quality of life, and to evaluate its safety and the impact on the patients' long-term survival outcomes.

Detailed description

Radiotherapy is one of the important treatments to improve the survival rate of breast cancer patients. Radiotherapy also has the risk of radiation lung injury, which can develop into pulmonary fibrosis, which seriously affects the quality of life of patients. Hyperbaric oxygen has received more attention in the field of delayed tissue damage caused by radiotherapy. In a hyperbaric oxygen environment, sufficient oxygen supply can improve the tissue after radiation by promoting the function of vascular endothelial cells and fibroblasts, and reducing the secretion of inflammatory factors. Low blood vessel density, low cell activity and low oxygen content in the "three low" state, thereby inhibiting the process of fibrosis and fiber atrophy after radiotherapy, and promoting tissue repair. Therefore, it has the potential value of treating chronic radiation injury. Can hyperbaric oxygen therapy be applied for breast cancer patients who were receiving radiotherapy, reduce the risk of radiation pneumonitis, prevent radiation pneumonitis and even radiofibrosis, and improve long-term survival? Therefore, we plan to prospectively enroll 380 breast cancer patients and randomly divide them into two groups. The treatment group will be given 30-40 hyperbaric oxygen therapy immediately after the end of radiotherapy, to study whether hyperbaric oxygen therapy reduces the risk of radiation pneumonia, and to evaluate hyperbaric oxygen The safety of treatment and its impact on the patient's quality of life and long-term survival outcomes provide an effective means to reduce the incidence of radiation pneumonia and improve the long-term quality of life.

Conditions

• Radiation Pneumonitis

Interventions

Type	Name	Description
BEHAVIORAL	hyperbaric oxygen therapy	hyperbaric oxygen therapy

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-01-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: China